title: Repeat treatment with icatibant for multiple hereditary angioedema attacks: FAST-2 open-label study.
abstract: BACKGROUND
  The For Angioedema Subcutaneous Treatment (FAST)-2, a phase III, double-blind, randomized, multicenter, placebo-controlled study (ClinicalTrials.gov identifier: NCT00500656), established the efficacy and safety of single injections of icatibant, a bradykinin B₂ receptor antagonist, in the treatment of hereditary angioedema (HAE) attacks. Here, we evaluate the efficacy and safety of repeated treatment with icatibant in adult patients experiencing HAE attacks during the FAST-2 open-label extension (OLE) phase.
  
  
  METHODS
  Patients completing the controlled phase were eligible to participate in the OLE phase and receive open-label icatibant (30 mg subcutaneously) for the treatment of cutaneous, abdominal, and/or laryngeal HAE attack(s) severe enough to warrant treatment. Time to onset of symptom relief was calculated for each attack. Descriptive analyses (median, 95% CIs) were performed for all attacks; post hoc analyses were conducted in patients with at least five icatibant-treated attacks throughout the FAST-2 OLE phase. Safety was also monitored.
  
  
  RESULTS
  Fifty-four patients received icatibant for 374 attacks (176 cutaneous, 168 abdominal, and 30 laryngeal). For cutaneous and/or abdominal attacks (attacks 2-5), the median times to onset of symptom relief ranged between 2.0 and 2.5 h. For all laryngeal attacks, the median times to regression (start of improvement) of symptoms ranged between 0.3 and 4.0 h. Post hoc analyses showed that the overall median time to onset of symptom relief was 2.0 h. Overall, 89.8% of attacks resolved with a single icatibant injection. No drug-related serious adverse events were reported.
  
  
  CONCLUSIONS
  These findings have demonstrated the efficacy and safety of repeated icatibant treatment for HAE attacks.
authors.affiliation: Department of Otorhinolaryngology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Baş
authors.forename: J
authors.initials: J
authors.lastname: Greve
authors.forename: T K
authors.initials: TK
authors.lastname: Hoffmann
authors.forename: A
authors.initials: A
authors.lastname: Reshef
authors.forename: W
authors.initials: W
authors.lastname: Aberer
authors.forename: M
authors.initials: M
authors.lastname: Maurer
authors.forename: S
authors.initials: S
authors.lastname: Kivity
authors.forename: H
authors.initials: H
authors.lastname: Farkas
authors.forename: B
authors.initials: B
authors.lastname: Floccard
authors.forename: F
authors.initials: F
authors.lastname: Arcoleo
authors.forename: L
authors.initials: L
authors.lastname: Martin
authors.forename: B
authors.initials: B
authors.lastname: Sitkauskiene
authors.forename: L
authors.initials: L
authors.lastname: Bouillet
authors.forename: P
authors.initials: P
authors.lastname: Schmid-Grendelmeier
authors.forename: H
authors.initials: H
authors.lastname: Li
authors.forename: A
authors.initials: A
authors.lastname: Zanichelli
mesh_terms: D000328:Adult; D054179:Angioedemas, Hereditary / Q000188:drug therapy*; D001920:Bradykinin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D065094:Bradykinin B2 Receptor Antagonists; D017326:Clinical Trials, Phase III as Topic / Q000379:methods; D015331:Cohort Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D015337:Multicenter Studies as Topic / Q000379:methods; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D055502:Secondary Prevention; D016896:Treatment Outcome
chemical_list: D065094:Bradykinin B2 Receptor Antagonists; C065679:icatibant; D001920:Bradykinin
keywords: For Angioedema Subcutaneous Treatment-2 (FAST-2); bradykinin B2 receptor antagonist; hereditary angioedema; icatibant; open-label extension phase